BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA CT580 RT

    MDR report key: 4506478 · Received January 7, 2015

    Report

    Report Number
    4506478
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Date of Event
    December 17, 2014
    Report Date
    January 7, 2015
    Manufacturer
    GE HEALTHCARE
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE EQUIPMENT WAS JUST INSTALLED; IT HAD NOT BEEN TURNED OVER TO THE HOSPITAL, AND WAS IN THE PROCESS OF BEING TESTED, WHEN A FAULTY ELECTRONIC PANEL CAUGHT FIRE. A REPAIR TECH WAS CALLED AND CAME TO REPLACE THE FAULTY ELECTRONIC PANEL. GE IS INVESTIGATING AND WILL SUBMIT A REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14587 OPTIMA CT580 RT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *